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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE: 17 Adverse Event Reports & Safety Profile

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17
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
17
As Primary/Secondary Suspect
1
Disabilities

Active Ingredient: ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE TARTRATE ·

First Report: 200902 · Latest Report: 20221119

What Are the Most Common ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE Side Effects?

#1 Most Reported
Insomnia
16 reports (94.1%)
#2 Most Reported
Paraesthesia
15 reports (88.2%)
#3 Most Reported
Drug abuse
15 reports (88.2%)

All ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Insomnia 16 94.1% 0 0
Drug abuse 15 88.2% 0 0
Paraesthesia 15 88.2% 0 0
Therapy partial responder 14 82.4% 0 0
Off label use 11 64.7% 0 0
Product use in unapproved indication 11 64.7% 0 0
Intentional product misuse 9 52.9% 0 0

Who Reports ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE Side Effects? Age & Gender Data

Gender: 8.7% female, 91.3% male. Average age: 41.5 years. Most reports from: ES. View detailed demographics →

Is ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 14 0 0
2022 1 0 1

View full timeline →

What Is ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE Used For?

IndicationReports
Migraine 16

Official FDA Label for ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\ERGOTAMINE

Official prescribing information from the FDA-approved drug label.